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硝西泮用于睡眠呼吸暂停患者:一项双盲安慰剂对照研究。

Nitrazepam in patients with sleep apnoea: a double-blind placebo-controlled study.

作者信息

Höijer U, Hedner J, Ejnell H, Grunstein R, Odelberg E, Elam M

机构信息

Dept of Otorhinolaryngology, Frölunda Specialist Hospital, Sweden.

出版信息

Eur Respir J. 1994 Nov;7(11):2011-5.

PMID:7875274
Abstract

We wanted to assess whether benzodiazepines worsen sleep apnoea, since their use in such patients has been controversial. Fourteen male patients with mild to moderate obstructive sleep apnoea were investigated in a placebo-controlled, double-blind study evaluating the influence of nitrazepam (NIT) on apnoea frequency and severity. Each patient was given oral nitrazepam 5 or 10 mg, or corresponding placebo, in a randomized order on three separate nights. Wash-out time was one week. A complete sleep study was undertaken at each study night. Eleven patients completed the study. Although there were individuals with marked variability in apnoea index between the three study nights, there was no significant change in apnoea index or minimum arterial oxygen saturation with any of the two nitrazepam dosages studied. Only 3 out of 11 patients had a higher apnoea index after both nitrazepam doses compared to placebo, and in these patients the increase in sleep-disordered breathing was of marginal clinical significance. Nitrazepam caused a modest increase in total sleep time and a decrease in rapid eye movement (REM) sleep. These results demonstrate that nitrazepam does not worsen sleep apnoea in patients with mild to moderate sleep apnoea. The previously reported sleep apnoea promoting effects of benzodiazepines may be restricted to a small subgroup of patients with sleep-disordered breathing.

摘要

由于苯二氮䓬类药物在这类患者中的使用一直存在争议,我们想评估其是否会加重睡眠呼吸暂停。在一项安慰剂对照、双盲研究中,对14名轻度至中度阻塞性睡眠呼吸暂停的男性患者进行了调查,评估硝西泮(NIT)对呼吸暂停频率和严重程度的影响。在三个不同的夜晚,以随机顺序给每位患者口服5毫克或10毫克硝西泮或相应的安慰剂。洗脱期为一周。在每个研究夜晚都进行了完整的睡眠研究。11名患者完成了研究。尽管在三个研究夜晚之间,个体的呼吸暂停指数存在明显差异,但在所研究的两种硝西泮剂量下,呼吸暂停指数或最低动脉血氧饱和度均无显著变化。与安慰剂相比,11名患者中只有3名在服用两种硝西泮剂量后呼吸暂停指数更高,而且在这些患者中,睡眠呼吸障碍的增加在临床上意义不大。硝西泮使总睡眠时间适度增加,快速眼动(REM)睡眠减少。这些结果表明,硝西泮不会使轻度至中度睡眠呼吸暂停患者的睡眠呼吸暂停加重。先前报道的苯二氮䓬类药物促进睡眠呼吸暂停的作用可能仅限于一小部分睡眠呼吸障碍患者。

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